Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Phase 4

Withdrawn

• Conditions: Heart Defects, Congenital
• Interventions: Drug: Rejuvesol; Procedure: Cardiac surgery

• Registration Number: NCT02485366
• Lead Sponsor: Duke University

Brief Summary

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27
• Study Start: 2020-06
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
• children undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

• refusal of blood products
• end-stage renal disease
• planned avoidance of CPB
• use of non- heparin anticoagulants
• participation in an experimental drug or device protocol within 30 days
• existing hemoglobinopathy
• allergy requiring washed RBCs
• immunocompromise requiring special blood product treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rejuvenated PRBCs	Cardiac surgery	The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
Rejuvenated PRBCs	Rejuvesol	The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).

Primary Outcome Measures

Name	Time	Method
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration	End of Surgery
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)	2 hours
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels	end of bypass

Trial Locations

Locations (1)

Duke Univerisity Medical Center; 🇺🇸 Durham, North Carolina, United States